Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000626965
Ethics application status
Approved
Date submitted
23/05/2011
Date registered
20/06/2011
Date last updated
25/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet versus face to face cognitive behaviour therapy for social phobia
Scientific title
In patients seeking treatment for social phobia internet cognitive behaviour therapy will be compared with face to face cognitive behaviour therapy on the reduction in social phobia scores.
Secondary ID [1] 262231 0
no
Universal Trial Number (UTN)
U1111-1122-3199
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Phobia 4143 0
Condition category
Condition code
Mental Health 268077 268077 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behaviour therapy delivered by the internet Six sessions/lessons of less than 50 minutes on a 7-10 day schedule following the content outlined in Andrews et al Treatment of Anxiety Disorders, Cambridge University Press, 2003. (Psychoeducation, dearousal strategies, cognitive therapy, graded exposure).
Intervention code [1] 3857 0
Behaviour
Intervention code [2] 266793 0
Treatment: Other
Comparator / control treatment
Cognitive behaviour therapy delivered in the clinic on a face to face basis. Six sessions/lessons of less than 50 minutes on a 7-10 day schedule following the content outlined in Andrews et al Treatment of Anxiety Disorders, Cambridge University Press, 2003.
Control group
Active

Outcomes
Primary outcome [1] 5226 0
Reduction in social phobia as demonstrated from scores on Social Interaction Anxiety Scale (SIAS) and Social Phobia Scale (SPS)
Timepoint [1] 5226 0
at 12 weeks after beginning treatment
Secondary outcome [1] 8809 0
Reduction in comorbid depression and anxiety as demonstrated from changes in the PHQ-9 and GAD-7
Timepoint [1] 8809 0
at 12 weeks after beginning treatment

Eligibility
Key inclusion criteria
accepted for treatment for social phobia at the St Vincent's Anxiety Disorders Clinic
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intake clinicians at the clinic do not offer treatment to people with comorbid psychosis, substance use disorder or severe personality disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects selected for treatment for social phobia at the clinic who have an email address and internet access will be invited to participate in the trial. They will know that have a 1 in 2 chance of being allocated to one of the treatment arms, internet CBT or face to face CBT. Allocation involved contacting the holder of the allocation schedule who was at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation using a web-based tool at www.random.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
30/10/2009
Date of last data collection
Anticipated
Actual
30/04/2010
Sample size
Target
120
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 4314 0
Government body
Name [1] 4314 0
NSW Institute of Psychiatry
Country [1] 4314 0
Australia
Primary sponsor type
Hospital
Name
Anxiety Disorders Clinic
Address
St Vincent's Hospital, 390 Victoria St, Darlinghurst, Sydney, NSW, 2010
Country
Australia
Secondary sponsor category [1] 3885 0
Government body
Name [1] 3885 0
NSW Institute of Psychiatry
Address [1] 3885 0
Cumberland Hospital, Fleet St, North Paramatta, NSW, 2151
Country [1] 3885 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6360 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 6360 0
Ethics committee country [1] 6360 0
Australia
Date submitted for ethics approval [1] 6360 0
Approval date [1] 6360 0
12/02/2009
Ethics approval number [1] 6360 0
HREC09/SVH/11

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35049 0
Prof Gavin Andrews
Address 35049 0
UNSW at St Vincent's Hospital, 390 Victoria St, Darlinghurst, NSW, 2010
Country 35049 0
Australia
Phone 35049 0
+612 8382 1405
Fax 35049 0
Email 35049 0
[email protected]
Contact person for public queries
Name 12396 0
Gavin Andrews
Address 12396 0
UNSW at St Vincent's Hospital, 390 Victoria St, Darlinghurst, NSW, 2010
Country 12396 0
Australia
Phone 12396 0
+61 2 8382 1405
Fax 12396 0
Email 12396 0
[email protected]
Contact person for scientific queries
Name 3324 0
Gavin Andrews
Address 3324 0
UNSW at St Vincent's Hospital, 390 Victoria St, Darlinghurst, NSW, 2010
Country 3324 0
Australia
Phone 3324 0
+61 2 8382 1405
Fax 3324 0
Email 3324 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.